MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 44" ( 112 CM) 8.8 ML, EXT SET W/2 MICROCLAVE®, REMV 2 GANG 4-WAY STOPCOCKS, ROTA; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number B33926

Device Problem Improper Flow or Infusion (2954)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 10/09/2019

Event Type  malfunction  

Manufacturer Narrative

It is unknown if the device is available for investigation.

Event Description

The event involved a 44" ( 112 cm) 8.8 ml, ext set w/2 microclave®, remv 2 gang 4-way stopcocks, rotating luer that the customer reported the iv tubing kinks easily when warmed causing softening of the plastic and collapsing of the tubing.The customer stated that the new iv extension sets become very pliant when warmed under a bair hugger or with the use of a fluid warmer in the operating room.It was reported that during an anesthetic case both the patient¿s iv tubing kinked despite standard ways of taping the tubing.The customer reported that the infusions that were running backed up into the patient¿s maintenance iv.An attempt to aspirate the ¿backed up¿ drugs from the maintenance tubing to avoid giving the patient a bolus of the drugs.The medication that "backed up" the maintenance line were phenylephrine, propofol, and sufentanil.The customer reported that the patient still received a bolus and had a hypertensive episode for which was treated with other medication to quickly lower the blood pressure.When administering the bolus to the second iv to treat the patient¿s blood pressure, that tubing was also found to be kinked off.The tubing was cooled off in the post anesthesia care unit (pacu) and the tubing returned to the normal non kinked form.There was patient involvement, no report of adverse event, and no report of a delay in critical therapy.This report captures the first of two devices.

Manufacturer Narrative

H10: no product samples were returned for investigation; however, a series of photographs were returned showing kinks in tubing that had been taped with a tension loop.One of the photos showed the tubing taped into a tension loop to be totally collapsed and likely occluding fluid flow.The kink was located along a straighter portion of the tension loop which suggests it may have occurred during the several prior taping/retaping efforts.A device history review (dhr) was not conducted because no lot number(s) was/were identified.The complaint was confirmed based on the photos returned, however, a probable cause cannot be determined without the return of the b33926 infusion set samples.

• Brand Name: 44" ( 112 CM) 8.8 ML, EXT SET W/2 MICROCLAVE®, REMV 2 GANG 4-WAY STOPCOCKS, ROTA
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 9257187
• MDR Text Key: 204928672
• Report Number: 9617594-2019-00368
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K970855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B33926
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PHENYLEPHRINE, UNK MFR.; PROPOFOL, UNK MFR.; SUFENTANIL, UNK MFR.; UNSPECIFIED TUBING SET.